SBIR-STTR Award

Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane. This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second key concept is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similar to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide- bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. In this phase I SBIR application we pursue two specific aims. In Specific Aim #1 the speech reception threshold as a function of bandwidth, in the presence of interfering speech from the sides, on normal and hearing- impaired subjects will be characterized. This will be done using techniques similar to those developed for the Hearing in Noise Test (HINT) under virtual auditory space conditions. In Specific Aim #2 methods of increasing the effective gain of the EarLens transducer at high frequencies will be tested. This will be achieved by distributing the current single magnet from the center of the EarLens platform to smaller magnets on its outer portions, which reduces the limiting effects of mass inertia at high frequencies. The audiograms, from subjects with mild to moderate hearing loss, driven with different EarLens configurations will be compared. Most of the six million hearing aid owners in the US, report various problems. Our goal is to design a high fidelity open canal hearing aid that more closely relates to normal auditory function thereby providing the brain with critical information so that it is able to segregate sounds originating from different directions and thus allow the listener to hear selectively and be able to understand desired speech from interfering speech. As an outcome of this approach, it is expected that there will be greater satisfaction with usage of the proposed hearing aid than those currently on the market

Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. The most frequently cited complaints include difficulty understanding speech in multi-talker situations, poor sound quality, dislike of the sound of their amplified voice, and unwanted whistling sounds caused by acoustic feedback. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. There are three key features needed to make this hearing aid a reality that differentiate it from conventional hearing aids. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane. This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues, in a similar manner to the functioning of a normal ear. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth sound and directionally dependent pinna cues with a microphone in an open canal configuration will perform better than conventional hearing aids, especially with the presence of competing talkers. In this phase II SBIR application four specific aims are proposed. All hearing aids require a "frequency-gain" prescription. However, current prescription methods are limited to frequencies below 6 kHz and the criteria for fitting have been limited to providing audibility and comfort with no considerations being made to preserve sound localization cues. To address these issues, a new high- frequency fitting prescription will be developed using a loudness model and tested on hearing-impaired subjects. In Specific Aim # 2, an initial EarLens system prototype will be bilaterally fit on hearing-impaired subjects. Proposed measurements include: (1) functional gain at audiometric frequencies between 0.125 to 10 kHz; (2) "spatial release from masking" or the ability to discern a target speech in the presence of symmetrically separated multi-talker maskers; (3) the "better ear advantage" in which the target and masker are arranged asymmetrically such that the target lies closer to one ear than the other. The latter two experiments are conducted with EarLens configured to only amplify sounds over specific bandwidths, which will range from 4 to 10 kHz. For Specific Aim # 3, we seek to build a behind-the-ear (BTE) prototype suitable for an external clinical trial - the "alpha prototype". A number of design changes including industrial design, mechanical design, user interface, and cable design are proposed. And in Specific Aim #4, a clinical trial of the EarLens hearing system will be conducted at four clinical sites located around the country. The objective of the clinical trial is to obtain sufficient data for a 510(k) submission to the FDA upon completion of the work proposed in this application. Most of the six million hearing aid owners in the US report various amplification problems. Our goal is to design a high fidelity open canal hearing aid that more closely relates to normal auditory function thereby providing the brain with critical cues so that it is able to segregate sounds originating from different directions and thus allow the listener to hear selectively and be able to understand desired speech from interfering speech. As an outcome of this approach, it is expected that there will be greater satisfaction with usage of the proposed hearing aid than those currently on the market.

Project Terms:
Acoustic; Acoustics; Address; Algorithms; Amplifiers; Audiogram; Audiometric Test; Audiometry; Auditory; Auditory Canal, External; Auditory Localization; Auditory system; Auricle; Auricle of external ear; Brain; Clinical; Clinical Trials; Clinical Trials, Unspecified; Contact Lenses; Contracting Opportunities; Contracts; Country; Coupled; Cues; Custom; Data; Ear; Ear Canal; Ear structure; Eardrum; Electromagnetic; Electromagnetics; Encephalon; Encephalons; Environment; Esthesia; External Acoustic Meatus; External auditory canal structure; Eye; Eyeball; Feedback; Frequencies (time pattern); Frequency; Goals; Hearing; Hearing Aids; Housing; Individual; Lead; Left; Legal patent; Loudness; Maps; Marketing; Masks; Measurement; Measures; Mechanics; Membrana Tympanica; Membrane; Methods; Methods and Techniques; Methods, Other; Modeling; Multi-Institutional Clinical Trial; Multi-center clinical study; Multi-center clinical trial; Multi-site clinical study; Multi-site clinical trial; Nervous System, Brain; Noise; Outcome; Output; Patents; Pathway interactions; Pb element; Perception; Performance; Phase; Procedures; Protocol; Protocols documentation; Qualifying; Reporting; Rest; SBIR; SBIRS (R43/44); Sensation; Shadowing; Shadowing (Histology); Silicones; Small Business Innovation Research; Small Business Innovation Research Grant; Solutions; Sound; Sound - physical agent; Sound Localization; Speech; Speech Intelligibilities; Speech Intelligibility; Stimulus; System; System, LOINC Axis 4; Techniques; Technology; Testing; Time; Transducers; Travel; Tympanic Membrane; Tympanic membrane structure; Voice; Work; base; clinical investigation; clinical research site; clinical site; computerized data processing; data processing; design; designing; ear drum; engineering design; experience; experiment; experimental research; experimental study; functional gain; hearing perception; heavy metal Pb; heavy metal lead; improved; innovate; innovation; innovative; lens; manufacturing process; membrane structure; middle ear; multi center clinical study; multi center clinical trial; multi site clinical study; multi site clinical trial; pathway; pinna; prototype; research study; satisfaction; signal processing; sound; sound frequency; sound perception; success